The Efficacy of Hibiscus Sabdariffa in Xerostomia

NCT ID: NCT06413550

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-03-31

Brief Summary

The goal of this [ type of study: Clinical trial] is to test effectiveness of Hibiscus Sabdariffa L. mouth rinse using the subjective dry mouth score as a primary objective and to assess the effect of that mix on the salivary flow rate and objective dry mouth score as a secondary objective.

Detailed Description

Xerostomia, defined as the subjective complaint of dry mouth, is one of the most prevalent and challenging adverse effects for head and neck cancer (HNC) patients treated with radiotherapy (RT) in definitive or adjuvant setting with or without concomitant chemotherapy (CHT). It represents a toxicity that can resolve over time, but often translates into a permanent condition that seriously affects swallowing, speaking and oral health, impairing several domains of patients' quality of life (QoL). Symptomatically, xerostomia may range from mild discomfort to severe oral disease accompanied by signs and symptoms affecting the oral cavity, including mucous membranes, lips, tongue, salivary glands and teeth. In the most severe cases it can cause severe depression.

Although radiation-induced xerostomia (RIX) is multifactorial, it is primarily the consequence of damage to the major and minor salivary glands that are usually included in the radiation fields or are in their close proximity. Thus, the severity of glandular injury and potential for recovery depends on the irradiated gland volume, the cumulative radiation dose and the capability of surviving cells to repopulate. Such injury causes diminution in function of the salivary glands and the consequences are reduction in saliva volume, consistency, pH, immunoglobulins and antimicrobial proteins.

The efficacy of Aqualief in treating xerostomia, or dry mouth, in patients contacting a randomized, placebo-controlled, double-blind trial was evaluated by a previous study. Aqualief contains two key ingredients, carnosine and karkadé (Hibiscus sabdariffa), which were selected and mixed with normalizing saliva pH and increasing saliva buffering activity. These parameters are often impaired in xerostomia patients, leading to acid-induced enamel and dental erosion and promoting the growth of aciduric bacteria.

Aqualief was found to normalize saliva pH to a neutral value and significantly increase the saliva flow rate in xerostomic patients. After six days of treatment, saliva pH was increased toward a neutral value, and the saliva flow rate was increased by almost 60%, compared to the basal value. This improvement was more than three times greater than that achieved with a placebo, which only increased resting salivation by 19%.

Conditions

Radiation-induced Xerostomia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Intervention group

patients in test group will topically apply 20 mL of Hibiscus Sabdariffa L. to the oral mucosa as oral rinse 3 times per day. Patients were advised to rinse 20 mL of Hibiscus Sabdariffa L. from the fourth week of radiotherapy to three months after radiotherapy.

Group Type: EXPERIMENTAL

Hibiscus Sabdariffa

Intervention Type: BIOLOGICAL

The fresh red Roselle plant was obtained; the red calyxes of Hibiscus Sabdariffa were separated from the plant and dried for a week at 25°C. The dried calyxes were ground to powder, kept in a sealed container, and stored in a refrigerator (4°C) until used. Aqueous Roselle calyx extract was prepared by adding 10 gm of the previously prepared powder to 100 ml of boiling water and then heated on a hot stirrer plate for 30 min. To remove the remnants, the mixture was filtered via Whatman No 1 filter paper (Whatman products, Springfield Paper Mill, Maidstone, UK). The water content of the filtered solution was evaporated using an air recirculation oven and then kept at 4°C in the dark until used to determine antibacterial effectiveness \[20\].

Control group

Patients in the control arm will topically apply 20 mL of 0.9% of normal saline rinses 3 times per day. Patients were advised to rinse with 20 mL normal saline from the fourth week of radiotherapy to three months after radiotherapy.

Group Type: PLACEBO_COMPARATOR

Hibiscus Sabdariffa

Intervention Type: BIOLOGICAL

The fresh red Roselle plant was obtained; the red calyxes of Hibiscus Sabdariffa were separated from the plant and dried for a week at 25°C. The dried calyxes were ground to powder, kept in a sealed container, and stored in a refrigerator (4°C) until used. Aqueous Roselle calyx extract was prepared by adding 10 gm of the previously prepared powder to 100 ml of boiling water and then heated on a hot stirrer plate for 30 min. To remove the remnants, the mixture was filtered via Whatman No 1 filter paper (Whatman products, Springfield Paper Mill, Maidstone, UK). The water content of the filtered solution was evaporated using an air recirculation oven and then kept at 4°C in the dark until used to determine antibacterial effectiveness \[20\].

Interventions

Hibiscus Sabdariffa

The fresh red Roselle plant was obtained; the red calyxes of Hibiscus Sabdariffa were separated from the plant and dried for a week at 25°C. The dried calyxes were ground to powder, kept in a sealed container, and stored in a refrigerator (4°C) until used. Aqueous Roselle calyx extract was prepared by adding 10 gm of the previously prepared powder to 100 ml of boiling water and then heated on a hot stirrer plate for 30 min. To remove the remnants, the mixture was filtered via Whatman No 1 filter paper (Whatman products, Springfield Paper Mill, Maidstone, UK). The water content of the filtered solution was evaporated using an air recirculation oven and then kept at 4°C in the dark until used to determine antibacterial effectiveness \[20\].

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Both genders, aged above 20 years.
• All patients must have complaint of xerostomia.
• Objective dry mouth score from ( 2-5).
• Subjective dry mouth score from (1-4).
• Patients must be able to make reliable decision or communications.

Exclusion Criteria

• - Smoking, Alcohol.
• Patient with history of any serious illness as malignancy.
• Patients with any autoimmune disease.
• Vulnerable groups such as pregnant females, prisoners, mentally and physically handicapped individuals.
• Known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

dalia Ghalwash

Role: STUDY_DIRECTOR

professor

Locations

Ahmed Maher Teaching Hosipital

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Fatma E.Sayed A Hassanein, PHD

Role: CONTACT

fatmahassanein@dent.asu.edu.eg

+201000093885

Asma A. Abou Bakr

Role: CONTACT

Asmaa.Aboubakr@bue.edu.eg

Facility Contacts

Fatma E.Sayed A Hassanein

Role: primary

fatmahassanein@dent.asu.edu.eg

+201000093885

Other Identifiers

Xerostomia & Hibiscus

Identifier Type: -

Identifier Source: org_study_id